Cortechs.ai | Cortechs.ai Announces Major FDA 510(k)-Pending  Update to NeuroQuant Software

Cortechs.ai Announces Major FDA 510(k)-Pending Update to NeuroQuant Software

MCH

San Diego, CACortechs.ai, a pioneer in AI-driven healthcare solutions, proudly announces a major update for its flagship product, NeuroQuant® v5.0, which is currently FDA 510(k) pending. This cutting-edge advancement marks a milestone in the field of neuroimaging AI, empowering healthcare professionals with unparalleled precision in diagnosing and monitoring neurological disorders.

This latest update to NeuroQuant® will expand the use of the software to support identification and evaluation of cerebral microhemorrhages on susceptibility-sensitive MRI sequences – small focal brain lesions commonly found in patients with Traumatic Brain Injuries (TBI), Cerebral Amyloid Deposition Diseases including Cerebral Amyloid Angiopathy (CAA) and Alzheimer’s Disease (AD), as well as patients with Amyloid Related Imaging Abnormalities (ARIA). 

“Our upcoming NeuroQuant® v5.0 application empowers healthcare professionals with precise data to inform diagnoses and monitor brain health. This innovation underscores our commitment to advancing neurological care for radiologists, neurologists, researchers, and patients alike.” says Brandon Steach, Head of Product at Cortechs.ai.

Nate White, Ph.D and Chief Technology Officer, says “Since the first commercial launch of NeuroQuant® in 2006, Cortechs continues to lead our industry, driving transformation through pioneering initiatives and fueling innovation in imaging-based AI technologies. The release of NeuroQuant® v5.0 strengthens our commitment to staying ahead of the curve and continuously pushing boundaries to provide AI-driven solutions to optimize patient care.”


About Cortechs.ai

Cortechs.ai is a leader in AI applications in radiology, using cutting-edge advances in medical imaging to revolutionize disease screening and early detection so patients can enjoy longer, healthier lives. The company develops and markets breakthrough medical device software that quantifies and tracks neurodegenerative diseases and assists in the detection of clinically significant cancer. Cortechs.ai’s industry-leading brain imaging analysis provides radiologists, neurologists, oncologists, and clinical researchers worldwide with a convenient and cost-effective means to quantify brain structures to help assess neurological conditions, such as Alzheimer’s disease, epilepsy, multiple sclerosis, brain trauma, and brain development abnormalities. The company has FDA-cleared products for use in the diagnosis and follow up of neurodegenerative and traumatic brain conditions, as well as prostate cancer. Please visit www.cortechs.ai for further information and follow us on Twitter, LinkedIn, and Facebook.

For more information on Cortechs.ai and the upcoming NeuroQuant® release, please contact:

___________

info@cortechs.ai  

+1 858 459 9700

More Resources

03/04/2026

Cortechs.ai and Siemens Healthineers Partner to Expand Global Access to NeuroQuant® Technologies

NeuroQuant® Lesion Surveillance will be integrated into the Siemens Healthineers Digital Marketplace to advance quantitative brain imaging worldwide.

02/25/2026

Cortechs.ai Announces MFDS (KFDA) Approval of Global-Leading NeuroQuant® V5 Platform in South Korea

MFDS approves NeuroQuant® V5 in South Korea, expanding AI-driven volumetric neuroimaging and clinical decision support.

02/24/2026

Financial Conflict Of Interest Policy Applicable To NIH Awards

02/20/2026

NeuroQuant® PET: FDA 510(k)-Pending Advancement in Molecular Dementia Imaging

FDA 510(k)-Pending NeuroQuant® PET delivers automated, standardized quantification for amyloid, tau, and FDG imaging in dementia care.

02/19/2026

How Cortechs.ai Protects ePHI: HIPAA‑Aligned Controls—and Beyond

Cortechs.ai’s HIPAA-aligned, defense-in-depth security safeguards ePHI across AI workflows—exceeding baseline compliance standards.

02/11/2026

NeuroQuant Normative Database: Advancing Age‑ and Sex‑Specific Brain Volumetry

Learn how the latest updates to the NeuroQuant normative database white paper strengthen age- and sex-specific brain volumetry and enhance clinical confidence.
Scroll to Top